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United States · US · US:71335-9756_b9ddda4a-9598-451d-abb2-f13f4ba4e67f

Hydralazine Hydrochloride

Orange BookUNIISPLATC C02DB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC02DB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7133597561
    30 TABLET in 1 BOTTLE (71335-9756-1)
  • ndc11
    7133597562
    60 TABLET in 1 BOTTLE (71335-9756-2)
  • ndc11
    7133597563
    120 TABLET in 1 BOTTLE (71335-9756-3)
  • ndc11
    7133597564
    90 TABLET in 1 BOTTLE (71335-9756-4)
  • ndc11
    7133597565
    10 TABLET in 1 BOTTLE (71335-9756-5)

Annotations

UNII (FDA Substance ID)
FD171B778Y
HYDRALAZINE HYDROCHLORIDE
RxCUI 82027
Orange Book
A205236
AAAAAAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FD171B778Y",
    "rxcui": "82027",
    "inchikey": "ZUXNZUWOTSUBMN-UHFFFAOYSA-N",
    "display_name": "HYDRALAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a1066707-2391-4918-8ded-600c017fde48": {
      "match": "brand_token",
      "title": "HYDRALAZINE HYDROCHLORIDE TABLET [CARDINAL HEALTH 107, LLC]",
      "spl_version": "4",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71335-9756_b9ddda4a-9598-451d-abb2-f13f4ba4e67f",
  "productndc": "71335-9756",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205236",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "May 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "May 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "50MG",
        "product_no": "003",
        "approval_date": "May 26, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "100MG",
        "product_no": "004",
        "approval_date": "May 26, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDRALAZINE HYDROCHLORIDE",
  "proprietary_name": "Hydralazine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205236",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Hydralazine Hydrochloride",
  "start_marketing_date": "20170526",
  "active_numerator_strength": "50"
}

Related drugs

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